Otthon
IDEGEN™ Handheld Spirometer
User Manual
english
thorlabor_eu_eng r141
2013-09-02
web: http://www.thorlabor.com
e-mail: thor@thorlabor.com
tel: +36 20 5837564
fax: +36 1 2093082
Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1 Intended use . . . . . . . . . . . . . . . . . . . . . . 4
1.2 Prediction algorithms age limits . . . . . . . . . . . . 6
2 Important safety warnings . . . . . . . . . . . . . . . . . 8
2.1 Danger of cross-contamination . . . . . . . . . . . . . 9
2.2 The Flowmeter . . . . . . . . . . . . . . . . . . . . . 9
2.3 The bacterial filter . . . . . . . . . . . . . . . . . . . . 9
2.4 Unforeseen errors . . . . . . . . . . . . . . . . . . . . 10
3 Description of the instrument . . . . . . . . . . . . . . . 11
3.1 General description . . . . . . . . . . . . . . . . . . . 11
3.2 Technical specification . . . . . . . . . . . . . . . . . 12
3.3 Labels and symbols . . . . . . . . . . . . . . . . . . . 16
4 Operation of the Otthon . . . . . . . . . . . . . . . . . . 18
4.1 Starting the device . . . . . . . . . . . . . . . . . . . 18
4.2 Turning off the device . . . . . . . . . . . . . . . . . . 19
4.3 Touchscreen . . . . . . . . . . . . . . . . . . . . . . . 19
4.4 Battery level . . . . . . . . . . . . . . . . . . . . . . . 20
4.5 The Main Menu . . . . . . . . . . . . . . . . . . . . . 20
5 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 35
5.1 Disinfecting the tube . . . . . . . . . . . . . . . . . . 35
6 Problem solving . . . . . . . . . . . . . . . . . . . . . . 39
6.1 Causes and solutions . . . . . . . . . . . . . . . . . . 39
7 Declaration of EC conformity . . . . . . . . . . . . . . . 40
CONTENTS
8 Limited Warranty Conditions . . . . . . . . . . . . . . . 41
3
1 Introduction
1.1 Intended use
User Category
The spirometer measures a series of parameters relating to human
respiratory function. The product is therefore intended for use by a
1 INTRODUCTION
doctor or by a nurse practitioner under the supervision of a doctor.
The product is therefore intended for use by a doctor or by a nurse
practitioner under the supervision of a doctor. Before first use please
disinfect the device. The device may will not in disinfected status
during the shipping.
Qualification and experience required
The correct use of the instrument, the interpretation of the test
results plus the maintenance of the instrument,and in particular the
avoidance of cross-infection, all requires qualified personnel.
Operating environment
The operation of the instrument is foreseen within a doctor’s office or
within a hospital.
The instrument is not intended for use in an operating theatre or in the
presence of inflammable liquids or detergents, nor in the presence of
inflammable anesthetic gases or oxygen or nitrogen gases.
The instrument is not designed to be used in direct air currents (e.g.
wind), sources of heat or cold, direct sun rays or other sources or light
or energy, dust, sand or any other chemical substances.
The user is responsible to check the suitability of the ambient
conditions both for the storage and for the use of the instrument.
4
Patient effect on the use of the instrument
A spirometry test should only be carried out when the patient is at
rest and seated in a suitable condition for the test. A spirometry
test requires the collaboration of the patient; the patient must make a
complete forced expiration in order to have a meaningful test result.
Do not use the spirometer in case of childrens above 4 years and
mens over 99 years. The defined interval of usage for the spirometer
related the patient age depends on the selected prediction algorithm.
1 INTRODUCTION
5
1.2 Prediction algorithms age limits
Age Height Weight
Reference Range [yr]
Male/Female Male/Female
Knudson 3…99 (3…99)
1 INTRODUCTION
ERS 93/ Knudson 3…99 (3…99)
ERS 93/Zapletal 3…99 (3…99)
Barcelona / Zapletal 3…99 (3…99)
Crapo Bass / Knudson 3…99 (3…99)
Pneumobil/ Knudson 3…100
Austrian 3…99 (3…99)
Polgar 3…17 (3…17)
NHANES III 8…80 (8…80)
Crapo 3…100 (3…100)
Hsu 7…17 (7…17)
Chinese Adult HK 2006 18…80 (18…80)
Chinese Children HK
2006
Swiss Adult 1996 18…60 (18…60)
Chinese Hong Kong 7…80 (7…80)
Gore 1995 - Australia 18…78 (18…78)
Stanojevic 2009 3…80 (3…80)
7…19 (7…19)
Range
[cm]
50…250
(50…250)
50…250
(50…250)
50…250
(50…250)
50…250
(50…250)
50…250
(50…250)
50…250
(50…250)
50…250
(50…250)
90…195
(90…195)
50…250
(50…250)
145…180
(145…180)
111…190
(111…180)
50…250
(50…250)
116…186
(119…174)
50…250
(50…250)
50…250
(50…250)
158…195
(145…187)
50…250
(50…250)
-
-
-
-
-
-
+
-
-
-
-
-
-
-
-
-
-
6
Limitations of use - Contraindications
An analysis of the results of a spirometry test is not in itself sufficient to
make a correct diagnosis of the patient’s clinical condition. A detailed
clinical history of the patient is also required together with any other
tests suggested by a doctor.
Test comments, a test interpretation and suggested courses of
treatment must be given by a doctor.
Any symptoms that the patient has at the time of the test must be
carefully considered before a spirometry test is made. The user is
responsible to assess both the mental and the physical capacity of
the patient to make a correct test and the user must also assess the
degree of collaboration for each test carried out.
Special attention should be given to testing elderly patients, children
and handicapped people. The instrument should never be used
when it is possible or probable that the validity of the results may be
compromised due to any such external factors.
1 INTRODUCTION
7
2 Important safety warnings
The safety and the correct performance of the instrument is warranted
only when the warnings and the safety rules are correctly observed.
The manufacturer accepts no responsibility for problems or damage
caused by the failure of the user to follow these instructions correctly.
The instrument must be used as described in the Users Manual
with particular attention to section 1.1 Intended use and only original
spares and accessories as specified by the manufacturer may be
used.
The maintenance operations detailed in this manual must be carried
out precisely. If these instructions are not followed this can cause
measurement errors and/or an incorrect interpretation of measured
2 IMPORTANT SAFETY WARNINGS
values.
Any modifications, adjustments, repairs or reconfiguration must be
made by the manufacturer or by a qualified person authorized by the
manufacturer. Never attempt to make a repair oneself.
High-frequency emissions may interfere with the correct operation of
the instrument. For this reason, certain minimum clearances (a few
meters) should be observed when high-frequency appliances such as
a TV, radio, portable phone etc and other electronic units are operated
at the same time in the same room.
If the instrument is connected to any other instrument, then in order to
maintain the essential safety characteristics according to IEC 60601-1
only equipment which complies to the current safety regulations may
be used.
For the recycling of the spirometer, accessories, plastic consumable
materials (bacterial filter), use only the appropriate containers or
better return all such parts to the seller of the instrument or to a
recycling centre. All appropriate local regulations must be followed.
8
2.1 Danger of cross-contamination
A disposable bacterial filter is required to connect a patient to the
spirometer to avoid cross-contamination. In order to avoid exposing
the patient to the critical danger of cross contamination before each
spirometry test a new single use bacterial filter must be used for each
patient.
2.2 The Flowmeter
Do not allow dust or foreign bodies to enter the Flowmeter, to avoid
incorrect functioning and possible damage.
The presence of any impurities such as hairs, sputum, threads etc
within the body of the Flowmeter may seriously compromise the
accuracy of the measurements.
2.3 The bacterial filter
We suggest you to use bacterial filter for every measurement
preventing cross-contaminations. The intended use of the requires
the bacterial filter. The bacterial filter should be placed on the end of
the tube so that it is between the Flowmeter and the patient. The blue
arrow on the device indicates the direction of the expiratory air flow in
that case the bacterial filter needs to be placed .
2 IMPORTANT SAFETY WARNINGS
FlowMeter with bacterial filter (illustration)
Any single use bacterial filter included with the instrument is supplied
only as a guide to the correct type and dimensions of the bacterial
9
filter required for this instrument, and they are clean but not sterile.
To purchase appropriate bacterial filter we suggest that you contact
your local distributor who supplied the spirometer.
The use of a mouthpiece made from an inappropriate material could
modify the bio-compatibility and could be the cause of an incorrect
functioning of the instrument and of incorrect test results.
The user is responsible to obtain the correct type of bacterial filter
for the instrument. Those required are standard type with an outside
diameter of 30mm; they are commonly used and in general easily
procured.
2.4 Unforeseen errors
2 IMPORTANT SAFETY WARNINGS
Errors in measurement or in interpretation can also be caused by:
• use by non-qualified or non-trained personnel, lacking ability or
experience
• user error
• use of the instrument outside the guidelines described in this
Users Manual
• use of the instrument even when some operational anomalies
may be encountered
• non-authorized servicing of the instrument
10
3 Description of the instrument
Otthon is a simple to operate, precise pocket spirometer (weight
only 300g) able to measure the most important functional respiratory
parameters with a quality control check on the test carried out.
3.1 General description
The instrument has the following user friendly features:
• Automatic internal calibration
• FVC, VC, MVV pulmonology measurements
• Patient database
• User friendly graphical interface, Quarter VGA (320X240 pixel),
256k colors
• No keyboard, the device is touchscreen euipped
• No moving parts
• Printing option
For a correct interpretation of the spirometry test results, the test
results must always be compared with the so-called normal or
predicted values which are calculated from the anthropometric data
of the patient inserted in formulas of normal values published by the
ERS (European Respiratory Society).
Otthon is intended for any doctor, from a family doctor to a specialist,
requiring a small and compact instrument able to make a full
spirometry test.
The instrument gives a simple summary of the test interpretation. This
test interpretation is based on the ATS (American Thoracic Society)
standards of 5 levels of obstruction, 5 levels of restriction and one of
normal spirometry, the instrument thus gives a valid support to the
doctor to make a diagnosis.
The sensor for flow and volume measurement is an Ultrasonic system
based on the IDEGEN™ ultrasonic multiple-path principle. This prin-
3 DESCRIPTION OF THE INSTRUMENT
11
ciple guarantees accuracy plus reproducibility of the measurement.
3.2 Technical specification
Here follows a complete description of the instrument and of the flow
and volume measurement system.
Parameters measured:
FVC, PEF, FEV1, FEV1/FVC, FEF2575, FEF2550, FEF25, FEF50,
FEF75, FEV3, FEV6, EV, ZeroTime, FET, PEFT, FIVC, PIF, FIV1,
FIV1/FIVC, FIT, VC, EVC, IVC, IC, IRV, ERV, TV, MVV
Memory capacity:
The instrument is able to store more than 20 000 patients and/or
measurements. The number is highly depends on the measurement type and the measurement length.
Display:
3 DESCRIPTION OF THE INSTRUMENT
Quarter VGA (320X240 pixels), 262k colors with touch-screen
Communication port/interface:
Connection to PC via USB or BlueTooth(optional)
USB printer connection with USB cable
Printing
The instrument can print to any HP deskjet and officejet printers (via
USB interface) that supports the PCL3 language.
Dimensions of the Device:
92x80x35 mm
Dimensions of the Flow tube:
⌀30 mm X 150 mm
Weight:
300 grams
Flow/volume measurement system:
IDEGEN™ technology
Measurement principle:
IDEGEN™ ultrasonic multiple-path
Maximum volume:
± 20 L
12
Flow range:
± 18 L/s
Volume accuracy:
± 3% or 50 mL
Flow accuracy:
± 3% or 50 mL/s
Sample rate:
100 Hz
Dynamic resistance at 14 L/s:
< 110 Pa/L/s
Battery:
Internal 3,7 V Li-Ion battery (Rechargeable via 5V 500mA miniUSB
charger)
Electrical protection:
Internal battery power supply
Level of electrical protection:
BF
Protection against water ingress:
IP32
Operating and storage conditions:
Temperature: 10-40°C
Relative humidity: 5 - 95% without condensation
IEC 60601-1-2 relevant tables:
Guidance and Manufacturer’s Declaration - Emissions
The Otthon is intended for use in the electromagnetic environment specified below. The customer or
user of the Otthon should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
The Otthon uses RF energy only for its inter-
RF Emissions, CISPR 11 Class B, Group 1
nal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
3 DESCRIPTION OF THE INSTRUMENT
Harmonics IEC 61000-3-2 N/A
Flicker IEC 61000-3-3 N/A
The Otthon is suitable for use in all establishments,
including domestic, and those directly connected to the
public low-voltage power supply network that
supplies buildings used for domestic purposes.
13
Guidance and Manufacturer ’s Declaration - Immunity
The Otthon is intended for use in the electromagnetic environment specified below. The customer or user
of the Otthon should ensure that it is used in such an environment.
Immunity Test
ESD ± 6kV Contact ± 6kV Contact
IEC 61000-4-2 ± 8kV Air ± 8kV Air
EFT
IEC 61000-4-4
3 DESCRIPTION OF THE INSTRUMENT
Voltage Dips/Dropout
IEC 61000-4-11
IEC 60601 Test
Level
±2kV Mains ±1kV
I/Os
±1kV Differential
±2kV Common N/A
>95% Dip for 0.5
Cycles 60% Dip
for 5 Cycles 30%
Dip for 25 Cycles
>95% Dip for 5
Seconds
Compliance
Level
N/A
N/A
Electromagnetic Environment
- Guidance
Floors should be wood, concrete, or ceramic tile. If floors
are synthetic, the r/h should be
at least 30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. Ifthe user
of the Armband requires continued operation during power
mains interruptions, it is recommended that Otthon be powered
from an uninterruptible power
supply or battery.
Power Frequency
50/60Hz
Magnetic Field IEC
61000-4-8
14
3A/m 3A/m
Power frequency magnetic fields
should be that of a typical commercial or hospital environment.
Guidance and Manufacturer ’s Declaration - Emissions
The Otthon is intended for use in the electromagnetic environment specified below. The customer or user
of the Otthon should ensure that it is used in such an environment.
Emission Test
Conducted RF, 3 Vrms 3 Vrms D=(3.5/V1)(Sqrt P)
EC 61000-4-6 150 kHz to 150 kHz to
Radiated RF 3 V/m 3 V/m
IEC 61000-4-3 80 MHz to 80 MHz to D=(7/EI)(Sqrt P)
Recommended Separation Distances for the Product
The Otthon is intended for use in the electromagnetic environment specified below. The customer or user
of the Otthon can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF Communications Equipment and the Otthon as recommended below, according
to the maximum output power of the communications equipment.
Max Output Separation (m) Separation (m) Separation (m)
Power (Watts) 150kHz to 80MHz 80 to 800MHz 800MHz to 2.5GHz
0.01 0.1166 0.1166 0.2333
0.1 0.3689 0.3689 0.7378
IEC 60601 Test
Level
80 MHz 80 MHz D=(3.5/E1)(Sqrt P)
2.5 GHz 2.5 GHz 800 MHz to 2.5 GHz
Compliance
Level
Electromagnetic Environment
- Guidance
Portable and mobile communications equipment should be
separated from Armband by no
less than the distances calculated/listed below:
80 to 800 MHz
Where P is the max power
in watts and D is the recommended separation distance
in meters. Field strengths
from fixed transmitters, as determined by an electromagnetic
site survey, should be less than
the compliance levels (V1 and
E1). Interference may occur in
the vicinity of equip ment containing a transmitter.
3 DESCRIPTION OF THE INSTRUMENT
1 1.1666 1.1666 2.3333
10 3.6893 3.6893 7.3786
100 11.6666 11.6666 23.3333
15
3.3 Labels and symbols
Product identification label
The identification label on the backside of the housing shows the
3 DESCRIPTION OF THE INSTRUMENT
product name, and additionally the following:
• Manufacturer’s name and address
• Product conformity marking, in line with the CE 93/42 guidelines
• Serial number of the device
• Web site of the manufacturer
16
Description of symbols used on the label
CE mark for medical devices. The product is conform to the
requirements of the 93/42/CEE medical devices directive.
Electrical safety symbol. In accordance with the EN 606011 the product and its component parts are of type BF and
therefore protected against the dangers of direct and indirect
contact with electricity.
Symbol for ”Manufacturer.” This symbol is adjacent to the
name and address of the manufacturer.
Symbol indicating the ”date of manufacture.” The symbol
is adjacent to the date that the product was manufactured,
expressed as four digits for the year.
Symbol indicating ”Not for general waste.” This symbol marks
devices that are reusable and not contaminated at the end of
the device life.
Symbol for ”Caution, consult accompanying documents” and
”Attention, see instructions for use.”
Symbol for ”Caution, consult accompanying documents” and
”Attention, see instructions for use.”
3 DESCRIPTION OF THE INSTRUMENT
17
4 Operation of the Otthon
4.1 Starting the device
The power push button is located on the bottom left side of the device.
To start the device:
1. Press and hold the power button.
2. You will hear a beep. You can now release the power button.
On the display of the device there will be appear a welcome
screen.
4 OPERATION OF THE OTTHON
3. A splash screen will appear on the display of the device.
18
4. After the splash screen, if enabled, the device usage tutorial
will appear. This will guide you through the basics of using
the device. You can navigate the tutorial using the on-screen
Previous and Next buttons.
5. Exit the tutorial by tapping the Finish button. This will bring up
the main menu.
4.2 Turning off the device
1. Finish all measurements and go back to the main menu.
2. Either
a) tap the on-screen OFF icon, or
b) press and hold the power button until the display turns
black.
4.3 Touchscreen
The Otthon has a large and responsive color touchscreen. All
manipulation of the device is done via the touching of on-screen
elements, like buttons. The graphical user interface elements of the
Otthon are designed to be big enough to facilitate operation of the
device with a finger. Nevertheless, the touchscreen will respond to
touching with objects made of any material.
4 OPERATION OF THE OTTHON
19
4.4 Battery level
The battery symbol in the upper right corner of the main menu
indicates the level of battery charge. The maximum charge is shown
by five indicator bars on the icon. When the battery level becomes
critically low (there are no indicator bars on the icon), the device will
automatically turn off.
4.5 The Main Menu
4 OPERATION OF THE OTTHON
The main menu of the device is made up of two main parts:
• Buttons to access the different functions of the device:
– Find patient
– New patient
– Quick measurement
– Settings
– OFF
• Status indicators:
– Battery level
– USB connection indicator
– Firmware version
– Current time
20
Find patient
Before any measurement can be done, a patient must be selected.
This is done using the Find patient dialog.
Search screen
Patients can be searched for either by name or ID. You can switch
between the two modes by tapping the leftmost button at the top of the
screen. To find a patient, enter a part of their name or ID, depending
on which mode you have selected, using the on-screen keyboard.
You can see the number of patients that match your search criteria
even while you are typing in the top left corner of the screen. To list
the patients whose name or ID includes the entered text, press Show.
To see a list of all patients, leave the text entry empty then press Show.
4 OPERATION OF THE OTTHON
21
Results screen
4 OPERATION OF THE OTTHON
If the list of patients does not fit in one page then you can navigate
between pages using the Previous and Next buttons. To go back to
the search screen, press Back. To select a patient from the list of
results, first highlight them by tapping on their name. Once you have
highlighted a patient, you can confirm your selection by tapping on
the highlighted entry a second time.
Patient profile screen
22
After a patient has been selected, their patient profile will appear.
This screen shows the information about the patient that’s kept in the
database of the device, such as:
• Name
• ID
• Date of birth
• Gender
• Ethnicity
• Weight
• Height
• Prediction formula
To change a patient’s name, ID, date of birth, gender or ethnicity,
tap on the top pencil icon to the right of the patient information area.
To change their weight, height or prediction formula, tap the bottom
pencil icon.
To permanently delete a patient along with all their previously
recorded measurements, tap the red X icon. The device will ask you
for confirmation before deleting the data.
At the bottom of the patient screen you can see three buttons. The
FVC button will start a new FVC measurement. The Review button
will take you to the list of previous trials. The Back button will take
you back to the results screen.
4 OPERATION OF THE OTTHON
23
FVC Measurement screen
4 OPERATION OF THE OTTHON
At first, most of the measurement screen is occupied by the real-time
flow-volume curve plot. At the top of the screen there are two buttons:
the Back button will take you back to the patient screen and the Retry
button will start the measurement again.
Next to the buttons there is an informational area, where the
instructional and interpretive messages of the device will appear.
Whenever a message is too long to fit into this area, a small green
arrow will appear indicating that there is more text to be displayed. To
view the full message, tap anywhere inside the text area.
When the device is ready to start the measurement, it will indicate this
in the informational area. Measurement is started automatically upon
detection of air flow inside the tube.
24
After the measurement has started, a Stop button will appear that’s
used to end the current measurement. Measurement will also
automatically end when no air flow is detected for 3 seconds.
Upon stopping the measurement, a panel will appear next to the plot
containing the calculated lung function indices of the measurements
in the on-going trial. You can navigate between the measurements
using the arrow icons. Because all of the different indices would be
too much to fit in one page, you can tap the table of indices to cycle
between three pages.
By default the plot on the left of the screen shows the flow-volume
4 OPERATION OF THE OTTHON
25
curve of the measurement. You can tap the plot cycle between the
flow-volume, volume-time and flow-time curves.
When multiple maneuvers have been performed, the best maneuver
will always be plotted with green color over the latest maneuver,
unless the best one is the latest.
To finish the trial, tap the Finish button at the top of the screen. This
will automatically take you to the review screen of the current trial.
Review screen
4 OPERATION OF THE OTTHON
First, a trial to be reviewed should be selected. The list of visits of the
currently selected patient will appear on the left of the screen. You
can scroll between pages of visits using the arrow icons beneath the
list. Select a visit by double tapping the date.
The list of trials contained in this visit will appear on the right side of
the screen. Select a trial by double tapping. You will be taken to the
review screen of the selected trial.
26
The review screen of a trial is for the most part identical to the
measurement screen as it appears after a measurement has been
completed. The only difference is the Action button. Tapping this
button will bring up the Other operations menu.
4 OPERATION OF THE OTTHON
In this menu, the following options are available:
Compare Compare the best maneuver of the current trial to the best
maneuver of a second trial. Selection of the second trial is
identical to the trial selection detailed above.
Post Perform a post-bronchodilator test. The measurement is
performed in the same way as a normal FVC measurement,
27
but after finishing the measurement, the Post measurement
screen will open. This a comparison screen between the best
maneuvers of the pre- and post-bronchodilator tests.
Print This option is only available when a compatible printer is
connected to the normal-sized USB connector of the device.
Selecting it will print out a report of the current trial. If you
have bluetooth module in your instrument, don’t forget to
select the proper interface (USB or BT thermoprinter) on the
”Options/Bluetooth settings” screen.
New patient
Use this option to add a new patient to the database of the device.
4 OPERATION OF THE OTTHON
Using the on-screen keyboard, you have to provide the following data
about the patient, in this order:
• First name
• Last name
• ID (you can use the Next ID button to automatically assign the
next unused ID)
• Year of birth
• Month of birth
• Day of birth
• Gender
• Ethnical group
• Weight
• Height
• Prediction algorithm
The device supports the following prediction algorithms:
• NHANES III
• Knudson
• Crapo
28
• Hsu
• Chinese Adult
• Chinese Child
• Austrian
After all the information has been provided, the new patient will be
created, and you will be automatically taken to their profile screen.
Quick measurement
Choose this option to quickly perform an FVC measurement, when
there is no need to archive the results. The measurement is
performed in the same way as is detailed in FVC Measurement
screen. If calculation of predicted values for the lung function indices
is desired, the With prediction option should be enabled for Quick
measurement in Settings. In this case, the device will ask for the
following information before a quick measurement: gender, age,
height and ethnicity.
Settings
4 OPERATION OF THE OTTHON
The Settings dialog is used for configuration and routine maintenance
of the device. There are four buttons available:
29
• Date & Time
• Calibration Check
• Service
• Options
Date & Time
Use this dialog to set the internal clock of the device to the correct
time for your time zone.
Calibration Check
4 OPERATION OF THE OTTHON
Calibration check is used to regularly validate the calibration of the
device, as required by the ATS/ERS recommendations.
Before performing a calibration check, you need to enter the current
environmental conditions into the device, such as: Temperature,
Humidity, Air pressure. Additionally, the size of the syringe to be used
should be specified. The device supports syringes of 1 and 3 Liters.
Press Next to proceed with the calibration check. A message will
appear, asking you to pull out the syringe fully.
30
Follow the instruction then press Ok to start the calibration check.
Fully empty then fill the syringe in quick succession three times. The
calibration check will automatically stop after filling the syringe for the
third time.
4 OPERATION OF THE OTTHON
The results of the calibration check will appear. The individual
expiratory and inspiratory volumes of the three measurement cycles
are displayed as well as their average values. The percentage of
difference from the expected volume is shown.
31
Service
Upon entering the Service option, the device will start sending flow
sensor data over the mini-USB interface. This enables the use of the
device with the ThorSoft desktop spirometry application for PC’s.
Options
The Options dialog is used to configure the device. The available
configuration options are:
4 OPERATION OF THE OTTHON
System of measurement Change the default units used for specify-
ing height and weight. Available options are Metric and Imperial.
Sound playback When enabled, the device will read out loud
the interpretive and quality control messages of the FVC
measurement.
Database stores patient name When disabled, the device will no
longer ask for and display patient names.
Interpretation protocol Used to toggle between interpretation pro-
tocols. Available options are ATS/ERS and NLHEP.
32
Calibrate LCD If you feel that the precision of the touchscreen
has deteriorated to a point where it affects usability, you can
recalibrate it using this option. An X will appear in each corner
of the device, one at a time. Tap each X at the exact center five
times in succession. The touchscreen is now recalibrated.
Reset database Wipe all recorded patient and visit data from the
device. A confirmation will appear before the data is deleted.
Please note that this operation is not reversible.
Device status Shows the following status information about the
device:
• VUSB: USB power supply voltage.
• VBATT: Battery voltage.
• V19: Touchscreen backlight voltage.
• USB connection status.
• Percentage of remaining battery life.
Select language Select the language in which the on-screen text is
displayed. Please note that this will not change the language
of sound playback.
4 OPERATION OF THE OTTHON
33
Startup animation Used to enable or disable the animated startup
4 OPERATION OF THE OTTHON
splash screen.
Flash usage To show how much of the storage space in the device
is being used, press Calculate. The calculation process might
take a long time (15-30 seconds).
Device usage tutorial Used to enable or disable the tutorial that
appears after turning on the device.
Quick measurement Toggle between quick measurement with and
without prediction. If prediction is enabled for quick measurement, the device will ask all the necessary information needed
for a prediction before every quick measurement.
OFF
Tapping the OFF icon will cause the device to power off.
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5 Maintenance
The Flowmeter used by Otthon guarantees the maximum measurement accuracy and has the great advantage of not requiring everyday
calibration. To ensure the maximum accuracy of the respiratory sensor, it is recommended to make a simple cleaning operation in case of
extensive use. It is a good practice from time to time to make a visual
check inside the tube to ensure that no hairs, dust or foreign bodies
of any kind have collected within the tube. Such an occurrence could
undermine the accuracy of the measurements.
Otthon is an instrument which requires very little maintenance. The
only regular maintenance operations required are:
• Cleaning and checking of the flow meter.
• Charging the battery.
ATTENTION
• In order to understand the proper disinfection process
please observe section 5.1 Disinfecting the tube.
Charging the battery
If the battery is empty or if the instrument will not switch on, then
the battery must be recharged. The proper charging method of the
Otthon in case of empty battery the device needs to be charged till the
flashing LED light turns off on the power button. If the LED flashing
ended the Otthon can be used in normal function. The charging
process may not suggested to suspend because the incorrect
charging time will cause the battery lifetime drop. ATTENTION
5 MAINTENANCE
• Do not charge during measurement.
5.1 Disinfecting the tube
The disinfection process was tested and validated using INSTRUMED
as disinfection liquid. If you intend to use disinfection liquid other than
35
INSTRUMED please consult your local sales representative.
INSTRUMED is a cleansing instrument disinfectant concentrate
which uses the latest in active agents, adjuvants and corrosion protection compounds, with a wide anti-microbial spectrum of application.
INSTRUMED is a yellow colored, mildly viscous product with a distinctive aroma, which allows it to be distinguished from other medical
instrument disinfectants.
5 MAINTENANCE
Preparation of the disinfectant solution
Using an appropriately large container, fill with 10 liters of tap water at
a temperature not warmer than 40 °C. To this add the disinfectant to
the appropriate cubic volume, for example in the case of a 2% solution
add 2dl, for a 1% solution add 1dl, and so on.
The working solution must always be prepared fresh before being
used.
Appropriate concentrations and exposure time
• 3% solution effective within 15 minutes
• 2% solution effective within 30 minutes
• 1% solution effective within 60 minutes
In the solution sterilization occurs with
• 5% solution effective within 3 hours
Disinfection steps
Step 1: Prepare 1%, 2% or 3% solution from the INSTRUMED as
Step 2: Cover hermetically one of the end of the flowtube with the
Step 3: Pour the prepared solution in the tube to leaving space only
described above
shipped cup.
for covering the other side the tube
36
Pouring the solution in the tube
5 MAINTENANCE
Step 4: Leave the solution in the tube for the specified time described
above
Step 5: Remove the upper cup and pour the solution out of the tube
Step 6: After flushing of the fluid carefully wipe the outer perimeter
of both ends of the flowtube with the disinfectant solution to
prevent the patient from cross infection
Wiping the outer perimeters with disinfectant
Step 7: Flush the tube with plenty of distilled water
37
Step 8: Wait for the tube to dry or dry the tube with a ventilator.
IMPORTANT WARNINGS
• Only the flowtube can be disinfected. Never put the device
itself under a running tap (or other liquid) as irreparable
damage may be caused.
5 MAINTENANCE
• If you intend to use disinfection liquid other than
INSTRUMED please consult your local sales representative.
ATTENTIONS using INSTRUMED
• It is forbidden to mix with other cleansers or disinfectants!
• R22: Harmful if swallowed
• R34: Causes burns
• S2: Keep out of the reach of children
• S13: Keep away from food, drink and animal feeding stuffs
• S25: Avoid contact with eyes
• S26: In case of contact with eyes, rinse immediately with
plenty of water and seek medical advice
• S28: After contact with skin, wash immediately with plenty
of water
• S36/37/39: Wear suitable protective clothing, gloves, goggles and facemasks
• S45: In case of accident or if you feel unwell seek medical
advice immediately (show the label where possible)
38
6 Problem solving
Here follow some of the possible problems which can occur when
using Otthon.
6.1 Causes and solutions
• Otthon does not switch on: the device doesn’t start when the
button is pressed, try the followings:
May the battery is discharged completely. In that case, connect
the device to its charger. Please let the device to be charged
about 4-5 hours. If the device is still not switching on call your
technical service department or organization.
• During operation of the machine it switches off
May the battery is empty. Please charge up the battery. Try to
switch it on again and follow the steps mentioned previously.
• Data in memory lost
The test data in memory have been lost. Call your technical
service department/organization.
6 PROBLEM SOLVING
39
7 Declaration of EC conformity
Manufacturer
THOR Laboratories Kft.
Bogdánfy u. 10/a., Budapest, 1117, Hungary
Product
Spirometer
Model number
Otthon
Classification
Class IIa, Council Directive 93/42/EEC of MDD, Annex IX, rule 10
Declaration
We hereby declare that the above listed products comply to the pro-
7 DECLARATION OF EC CONFORMITY
visions of the Council Directive 93/42/EEC as amended by Directive
2007/47/EC for medical devices. All supporting documentation is retained under the premises of the manufacturer.
Applied standards
EN 60601-1:2006/AC:2010 ISO 15223-1:2012
EN 60601-1-2:2007/AC:2010 EN 1041:2008
EN 60601-1-6:2010 EN ISO 14971:2012
EN 62366:2008 EN ISO 26782:2009
EN 62304:2006
Notified Body
SGS United Kingdom Ltd. Systems & Services Certification;
202B World Parkway Weston super Mare, BS22 6WA UK
EC Certificates
Directive 93/42/EEC HU09/6306
EN ISO 13485:2012 HU09/6307
ISO 9001:2008 HU09/6308
40
0120
8 Limited Warranty Conditions
This product together with its standard accessories is guaranteed for
a period of ONE YEAR from the date of purchase. In the case of
any warranty claims the relevant sales invoice (or another proof of
purchase document) must be submitted.
The instrument must be checked at the time of purchase and any
claims must be made immediately in writing.
This warranty covers the repair or the replacement (at the discretion
of the manufacturer) of the product or of the defective parts without
charge for the parts or for the labor.
All consumable parts are specifically excluded from the terms of this
guarantee.
The warranty is not valid, and the judgment of the manufacturer’s
technicians is final, in the following cases:
• If the fault is due to an improper operation of the machine, or if
the installation does not conform to the current safety norms in
the country of installation.
• If the product is utilized differently from the use described in the
Users Manual.
• If any alteration, adjustment, modification or repair has been
carried out by personnel not authorized.
• If the fault is caused by lack of or incorrect routine maintenance
of the machine.
• If the machine has been dropped, damaged or subjected to
physical or electrical stress.
• If the fault is caused by the mains or by another product to which
the instrument has been connected.
• If the serial number of the instrument is missing, tampered with
and/or not clearly legible.
The repair or replacement described in this warranty is supplied for
goods returned at the customer’s expense to our certified service
centre. For details of these centers please contact your supplier of
8 LIMITED WARRANTY CONDITIONS
41
the spirometer or contact the manufacturer directly.
The customer is responsible for the transportation and for all transport
and customs charges for the delivery of the goods both to and from
the service centre.
Any instrument or accessory returned must be accompanied by a
clear and detailed explanation of the defect or problem found.
The manufacturer reserves the right to modify the instrument if
required, and a description of any modification made will be sent along
with the returned goods.
This manual is attached to the following Otthonspirometer serial
number
OTH-
8 LIMITED WARRANTY CONDITIONS
42
Manufacturer:
THOR Laboratories Kft.
Bogdánfy u. 10/a., Budapest, 1117, Hungary
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